Gestational Weight Gain and the Electronic Medical Record (WATE)

May 10, 2016 updated by: Scott Graziano, Loyola University

WATE Study - Gestational Weight Gain and the Electronic Medical Record

Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM) recommended weight gain. To date, there are no randomized controlled trials studying the use of the electronic medical record to alert providers to initiate the counseling of patients on the IOM gestational weight gain recommendations.

In the investigator's planned study intervention, using the EPIC EMR system, an electronic alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This alert will remind providers to counsel patients on the recommendations for gestational weight gain. The control group will receive standard prenatal care, without electronic alerts generated regarding BMI and gestational weight gain.

The investigators hypothesize that a higher percentage of patients who receive the intervention will meet the IOM guidelines for weight gain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant with a single intrauterine gestation
  • Present for new OB visit up to 13 weeks and 6 days gestation

Exclusion Criteria:

  • They have a multiple gestation pregnancy
  • They are under the age of 18
  • They do not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMR intervention
Patients will have an electronic medical record popup/highlight in their chart, displaying the recommended guidelines for weight gain in pregnancy.
Other: EMR Intervention
Electronic medical record flag/notification in the patient's chart
No Intervention: Control
The patient's medical record will be displayed as usual, with no flag or highlight for weight gain recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight gain
Time Frame: At delivery, average of 40 weeks from enrollment
Primary outcome will be measured as the percent of patients who achieve their recommended weight gain goal in pregnancy (IOM guidelines)
At delivery, average of 40 weeks from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient perception
Time Frame: At end of pregnancy, average of 40 weeks from enrollment
Survey to patients at the end of pregnancy regarding how patients perceive and are influenced by EMR notifications and counseling
At end of pregnancy, average of 40 weeks from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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